Ostomy appliance

ABSTRACT

An ostomy appliance comprising an adhesive barrier member (or base plate), said barrier member having a hole for receiving a stoma, ureter, or catheter and barrier wafer to be attached to the wearer&#39;s abdomen, back, or chest; an outer receiving member or bag releasably attached to the adhesive barrier member, said bag having a hole for receiving wastes exiting the stoma, ureter or catheter; and a disposable inner bag liner releasably attached to the adhesive barrier member wherein the disposable inner bag liner having a hole for receiving wastes exiting the stoma, ureter or catheter is attached releasably to the adhesive barrier member in a first coupling area by first coupling means and the outer receiving member is attached releasably to the adhesive barrier member by second coupling means, in which the first and second coupling areas are in the form of one or more coupling rings and the first and second coupling means are in the form of matching coupling rings and wherein the outer diameter of the first coupling means is smaller than the inner diameter of the second coupling means. Offers provide a separate, flushable inner bag enabling a safe, hygienic and discreet management of the collected waste with maximum safety against soiling parts thereof not to be substituted when changing the collecting bag.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The present invention relates to an ostomy appliance comprising abody side member, a receiving bag and a disposable bag liner; and adisposable bag liner for use together with an ostomy appliance.

[0003] In connection with surgery for a number of diseases in thegastrointestinal or urinary tract a consequence is, in many cases, thatthe colon, the ileum or the ureter has been exposed surgically and thepatient is left with an abdominal stoma, or, in nephrostomy orureterostomy, the ureter or a catheter is exposed in the back or thechest region or abdominal region, and the effluents or waste products ofthe body, which are conveyed through these organs, are dischargedthrough the artificial orifice or opening and are collected in acollection bag, which is usually adhered to the skin by means of anadhesive wafer or plate having an inlet opening for accommodating thestoma/ureter/catheter. Also in connection with a fistula, the patientwill have to rely on an appliance to collect the bodily materialemerging from such opening.

[0004] Ostomy appliances are well known. Such appliances may betwo-piece or one-piece appliances. In both types of appliances, anadhesive barrier member (or base plate) is attached to the wearer'sabdomen/back/chest. In case of a one-piece appliance, a receiving memberor bag is attached to the base plate. In case of a two-piece appliance,the adhesive barrier member forms part of a body side member and areceiving member or bag is attached releasably to the body side ostomymember for receiving exudates from the stoma.

[0005] When using one-piece appliances, the whole appliance, includingthe adhesive skin barrier securing the appliance to the skin is normallyremoved and replaced by a fresh appliance. When using two-pieceappliances, the body side ostomy ember is left in place up to severaldays, and only the receiving member or bag attached to the body sidemember is replaced. The attachment means for attaching an ostomyreceiving bag may be a system known per se comprising matching couplingrings or matching flanges and adhesive surfaces engaging with andsealing against a flange area of the body side member.

[0006] The service time of the body side ostomy member depends on theamount and aggressiveness of the exudates and of the tightness of thesealing between the ostomy and the body side ostomy member.

[0007] A known major problem with such receiving bags is that it can bedifficult to dispose of the used bag in a convenient and hygienicmanner. Some ostomists will cut the used bags open, e.g. by cutting offan edge thereof and depositing the contents into a WC for flushing awayand disposing or depositing the empty bag in a waste bin. Such disposalof used bags and the contents therein is indeed unhygienic andunpleasant for the user, and in view of this a number of proposals havebeen made for ostomy bags which may be flushed down a WC.

[0008] 2. Description of the Related Art

[0009] Thus, U.S. Pat. No. 5,423,782 (Wolrich) discloses a disposableostomy bag liner apparatus including a unitary flexible bag having amain body portion, a tapered portion and a flange portion in which thetapered portion is disposed adjacent the main body portion and together,the main body portion and tapered portion define an interior portion ofthe bag for receiving and hold intestinal waste material. The patentdiscloses a bag liner for use by colostomy and some ileostomy patientswhich is easy to install in a conventional ostomy bag, which hasprovisions to allow for escape of gas admitted into the liner and whichis relatively inexpensive to produce.

[0010] EP Patent No. 0 768 848 (Welland Medical Limited) discloses abiodegradable, flushable ostomy bag liner comprising inner walls formedfrom polyvinylacetate/polyvinylalcohol film of a grade whichdisintegrates within 60 seconds in water at 50° C. but retains itsstructural integrity in water at 25° C. for at least two days, outerwalls formed from a non-woven fabric which disintegrates in water at 25°C., means defining an opening in the inner and outer walls for receivingbodily waste from the stoma patient, an adhesive flange being secured toat least an inner wall of the liner and surrounding the said opening,wherein the walls of the inner and outer bags are unconnected and form anon-laminar arrangement over the greater part of their area, but areconnected around their peripheral margins and in the region of theadhesive flange.

[0011] EP Patent No. 0 703 762 (Welland Medical Limited) forms basis forthe invention disclosed in EP Patent No. 0 768 848 above and discloses adrainage bag for receiving bodily waste, the drainage bag containing anouter bag, a water-impermeable inner bag enclosed within the outer bag,the inner bag being of a structure which is weakened upon immersion in aWC bowl such that it becomes limp and is less buoyant thereby enablingit to be flushed away easily, and means defining an orifice to enablebodily waste to be received by the inner bag in which the outer bag iswater-impermeable and is formed from a material which acts as a barrierto flatus gases. The outer bag is provided with a flatus filter, theinner bag is permeable to flatus gases, and the outer and inner bags aredetachably secured together in the region of the orifice.

[0012] GB Patent Application No. 2 306 889 (Alcare Co Ltd) discloses abody waste receiving appliance comprising an adhesive plate with anopening to a wastes discharge hole or opening formed on the surface of ahuman body, a first flange secured to the non-adhesive side of saidadhesive plate and having an opening corresponding to the opening ofsaid adhesive plate, a second flange detachably mounted at the oppositeside, with reference to said adhesive plate, of said first flange andhaving an opening corresponding to the opening of said first flange andhaving an opening corresponding to the opening of said first flange, anouter pouch secured at the opposite side, with reference to the adhesiveplate, of said second flange and having an opening corresponding to therespective openings of said adhesive plate, said first flange and saidsecond flange, and an inner pouch for receiving the body wastes throughthe respective openings of said adhesive plate and said first flange,said inner pouch being housed inside the outer pouch in such a manner asto be separable therefrom, said outer pouch being formed of anon-water-soluble film, while said inner pouch being formed of awater-soluble film which is dissolved or disintegrated in water, saidinner pouch being replaceable.

[0013] GB Patent Application No. 2 265 832 (Bettison) discloses anostomy bag with an inner dividing means in the form of an open, innerbag communicating with the internal space of the outer bag having theoverall effect of dividing the interior of the bag into an inlet sectionand an outlet section communicating in the vicinity of the bottom of thebag.

[0014] EP Patent Application No. 0 821 925 (Quacquarella) discloses anostomy appliance comprising a reusable outer bag and a disposable innerbag, means for securing the two bags together and to the stoma, meansfor inserting and removing the inner bag from the outer bag, and meansfor closing the outer bag once the inner bag is in place.

[0015] The purpose of the present invention is to provide an ostomyappliance combining the advantages of using separate, flushable innerbags with a safe, hygienic and discreet management of the collectedwaste with maximum safety against soiling parts of the appliance not tobe substituted when changing the inner bag. Non of the above-referencedpatents disclose an ostomy bag comprising a disposable inner bag whichstays with full engagement with the coupling area of a body side memberafter detaching the outer bag.

SUMMARY OF THE INVENTION

[0016] The present invention relates to an ostomy appliance comprising abody side member, a receiving bag and a disposal bag liner.

[0017] The present invention furthermore relates to a disposable bagliner for use together with an ostomy appliance.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The invention is disclosed more in detail with reference to thedrawings in which

[0019]FIG. 1 shows an embodiment of an ostomy appliance inner bag of theinvention,

[0020]FIG. 2 shows a section of the embodiment of FIG. 1 along the line2-2,

[0021]FIG. 3 shows the embodiment of an inner bag shown in FIG. 1 whenplaced in mesh with a coupling ring attached to a base plate,

[0022]FIG. 4 shows another embodiment of an ostomy appliance inner bagaccording to the invention with a separate coupling in mesh with acoupling ring attached to a base plate,

[0023]FIG. 5 shows a further embodiment of an ostomy inner bag with aseparate coupling ring in mesh with a separate coupling ring attached toa base plate, and

[0024] FIGS. 6-8 show preferred dimensioning dimensions.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

[0025] The invention relates to an ostomy appliance comprising anadhesive barrier member (or base plate), said barrier member having ahole for receiving a stoma, ureter, or catheter and barrier wafer to beattached to the wearer's abdomen, back or chest; an outer receivingmember or bag releasably attached to the adhesive barrier member, saidbag having a hole for receiving wastes exiting the stoma, ureter orcatheter; and a disposable inner bag liner releasably attached to theadhesive barrier member wherein the disposable inner bag liner having ahole for receiving wastes exiting the stoma, ureter or catheter isattached releasably to the adhesive barrier member in a first couplingarea by first coupling means and the outer receiving member is attachedreleasably to the adhesive barrier member by second coupling means, inwhich the first and second coupling areas are in the form of one or morecoupling rings and the first and second coupling means are in the formof matching coupling rings and wherein the outer diameter of the firstcoupling means is smaller than the inner diameter of the second couplingmeans.

[0026] The present invention fulfils the purpose of the invention asstated above in that the coupling rings for attaching the inner bagliner are placed in such a relationship to each other that the outerreceiving member may be detached separately leaving the inner bag liner,which is closed apart from the hole for receiving wastes, in fullengagement with the first coupling area and thus, a barrier is providedagainst contact between the wastes exiting from the stoma and thecoupling system for the outer receiving member and provides an extrasafety against contact between the wastes exiting from the stoma and theskin and guide the waste into the bag liner.

[0027] Furthermore, the present invention will not jeopardise the optionof using a convex element known per se for e.g. retracted stomas.

[0028] The use of a coupling ring furthermore gives a better safetyagainst trapping of air in the inner bag liner when disposing the samein the WC bowl for flushing as the opening of the bag is kept open.

[0029] The shape of the inner bag liner is preferably in the form of abag which is narrower at the open inlet end and wider in the closed endwhich maximises the capacity of the bag and minimises the risk oftrapping air which might hamper the disposal by flushing.

[0030] An adhesive barrier member (or base plate) and an outer receivingmember or bag for use in an ostomy appliance according to the inventionmay be made from materials conventionally used for the preparation ofostomy appliances in a manner known per se in the field.

[0031] Coupling rings for use in the present invention may be anyconventional coupling rings for coupling adhesive barrier member (orbase plate) and receiving bags such as the coupling rings disclosed inWO94/18919

[0032] In one embodiment of the invention, the ring is flexible in adirection perpendicular to the plane of the ring and relatively stiff inradial direction rendering the detachment of the bag more easy. This maye.g. be obtained by providing the ring with weakening zones known per sebeing weaker in non-radial direction.

[0033] At least the outer edge of the ring may suitably be of arelatively soft material providing friction sealing enhancing the safetyagainst leak.

[0034] In another embodiment of the invention, the ring is made from amaterial being biodegradable.

[0035] The ring may be sealed to the inner bag liner or, in a furtherembodiment of the invention the ring is a separate ring which may beused several times. In this embodiment, the open end of the inner bagliner is preferably elaborated in a manner enabling a locking of the bagby passing the open end of the bag through the ring and folding the endof the bag back outside of the ring so that the ring is enclosed in thefolded part of the bag and the bag is locked when engaging the ring withthe coupling ring of the base plate. When disposing the used bag, thebag is detached and its surface having been in contact with the wasteexiting the stoma is kept from contact with the coupling parts ensuringa high degree of safety against soiling the coupling ring, the baseplate, or the hands of the user.

[0036] In the alternative, the ring is placed inside the open or freeend of the bag liner and the open or free end of the bag is foldedinside the ring so that the ring is enclosed in the folded part of thebag and the bag is locked when engaging the ring with the coupling ringof the base plate.

[0037] In this embodiment, the open or free end of the bag liner willstretch into the bag and form a sealing against the side of the stoma.It is preferred that the outer rim of the open end of the bag liner isprovided with a layer of adhesive which may form a direct sealingagainst the stoma and reduce the risk of soiling the coupling area ofthe base plate which is intended to stay on the skin for a longer periodof time than the individual receiving bags. In this embodiment it may bepreferred to use the separate coupling ring as a disposable ring. Inthis embodiment it is preferred that the bag is wider in the closed endfor facilitating the emptying of the bag from air when dumped in the WCbowl for flushing.

[0038] In one embodiment of the invention, the first and second couplingmeans are in the form of concentric coupling rings.

[0039] In another, preferred embodiment of the invention, the first andsecond coupling areas are located on one coupling ring for coupling areceiving member to the adhesive barrier member wherein the firstcoupling surface is located at the inner surface of the coupling ringand the second coupling surface is located at the outer surface of thecoupling ring. This embodiment will provide extra safety against leak orunintended detachment when using a locking ring as disclosed in WO94/18919 also locking the ring of the inner bag liner.

[0040] It is preferred that the first coupling surface is in the form ofa groove in the inner surface of the coupling ring as this provides areliable safety against leak and also clearly indicates when thecoupling means of inner bag liner engages properly with the couplingring. This renders the use more safe as it is often difficult to obtaina good view of the area of the stoma where the bag is to be attached forensuring a proper placement without having access to a mirror.

[0041] In another preferred embodiment, the first coupling surface is inthe form of a recess at the proximal side or beneath the coupling ringof the base plate giving the same advantages as stated above. For thisembodiment it is preferred that the coupling surface of the ring of theinner bag liner is located on an outwardly extending rib.

[0042] The inner bag liner may be made from a material being essentiallywater-soluble with the proviso that it is not dissolved until disposalthereof. Such material may e.g. be of the kind mentioned in EP PatentNo. 0 768 848.

[0043] The inner bag liner is preferably made from a material not beinggas tight and thus permitting intestinal gasses entering the bag todiffuse through the inner bag liner without giving rise to ballooningfor management by a conventional gas venting and filtering system placedon the outer bag. The inner bag liner is preferably impermeable to waterand water vapour in order to avoid leaking of liquid or passing of watervapour which would start a deterioration of the outer layer of the bagliner.

[0044] Thus, the inner bag liner is suitably made from a thin,water-impermeable sheet, which is not gas-tight. The bag liner issuitably in the form of a coextruded or laminated sheet having a layerof water soluble material such as PVA, PVAL or EVAL at the outersurface. The inner surface may suitably be made from a material whichmay be processed into a thin layer without pin holes such as PE, EVA,PVC, PP, or a polyester which layer is impermeable for water vapour. Theouter material may e.g. be in the form of a sheet or a non-wovenmaterial.

[0045] In a second aspect, the invention relates to a disposable innerbag liner for receiving effluents or waste products of the body for usetogether with an ostomy appliance comprising an adhesive, flexible skinbarrier member for securing the appliance to the user's skin saidbarrier member having a hole for receiving a stoma, ureter or catheterand barrier wafer to be attached to the wearers abdomen back or chest;and a collection bag having a hole for receiving wastes exiting thestoma, ureter or catheter, wherein the disposable inner bag liner has ahole for receiving wastes exiting the stoma, ureter or catheter and isreleasably attachable to the adhesive barrier member in a first couplingarea by first coupling means and the collection bag is releasablyattachable to the adhesive barrier by second coupling means, in whichthe first and second coupling areas are in the form of one or morecoupling rings and the first and second coupling means are in the formof matching coupling rings and wherein the outer diameter of the firstcoupling means is smaller than the inner diameter of the second couplingmeans.

[0046] In a preferred embodiment of the disposable inner bag liner, thefirst coupling means is in the form of a coupling ring for engaging witha first coupling area located at the inner surface of a coupling ringfor coupling a collection bag to the adhesive barrier member.

[0047] In a further, preferred embodiment of the dispersible inner bagliner of the invention, the first coupling means is in the form of anexchangeable inner bag coupling ring not being attached to the bagliner.

[0048] In a further, preferred embodiment, the exchangeable couplingring has an inner diameter d₁ and an outer diameter d₂ and the flattenedinner bag has an open end having a width W and the inner bag liner in anopen state having an essentially circular opening has a diameter D1wherein the relation D1<d2 is fulfilled.

[0049] Still further, in a preferred embodiment, the open end with W ofthe inner bag liner and the coupling ring outer diameter d₂ fulfils therelation W>d₂

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0050] The invention is now explained more in detail with reference tothe drawings showing preferred embodiments of the invention.

[0051] In FIG. 1 is shown an embodiment of an inner bag liner of theinvention in the form of a bag generally designated by 1. The bag 2 ismade from a thin, water-impermeable sheet, which is preferably notgas-tight. This allows air to pass through the inner bag liner to letout through a conventional ostomy filter system for managing gas, and nospecial precautions has to be taken in order to prevent ballooning. Theinner bag liner preferably has a general trapezoid shape being narrowerin the upper inlet end 3. In this embodiment, the inlet is in the formof an opening 4 at the side of the bag, near the top. The bag has aninner bag coupling ring 5 secured to the bag which may engage with acorresponding coupling ring situated on a barrier member or base plate(not shown). FIG. 2 shows a sectional view of the inner bag shown inFIG. 1 along the line 2-2. The inner bag coupling ring 4 is situated atthe outer side of the bag 2 surrounding an inlet opening 4.

[0052]FIG. 3 shows a sectional view of a base plate generally designated10 having a hole 11 for accommodating a stoma and a coupling ring 12 forattaching a conventional collecting bag and showing the embodiment of aninner bag 1 shown in FIGS. 1 and 2 when placed with the inner bagcoupling ring 5 in mesh with a groove 13 at the inner side of couplingring 11 of the base plate. As will be appreciated, a conventionalcollecting bag (not shown) may be attached to the coupling ring 12enclosing the inner bag liner.

[0053] Reference is made to FIG. 4 showing another embodiment of anostomy appliance inner bag according to the invention in mesh with aconventional coupling ring 12 for attaching a conventional collectingbag (not shown). Only the upper inlet end 13 has a general trapezoidshape is shown. The bag 14 is folded over a separate inner bag couplingring 15 with the free end 16 outside the bag and the inner bag couplingring 15 is shown in mesh with a groove 13 at the inner side of thecoupling ring 12 of the base plate 10. As appears, the inner bag lineris squeezed sealingly between the inner bag coupling ring 14 and thecoupling ring 12.

[0054]FIG. 5 shows a detail of a further embodiment of an ostomy innerbag 14 according to the invention having a separate coupling ring 17having an outwardly extending rib 18 for engaging with the lower, inneredge 19 of the coupling ring 12. In this embodiment, the attachment ofthe coupling ring 12 to the adhesive wafer or plate 20 of the base plate10 is located radially shifted outwards from the inner edge 19 of thecoupling ring 12 allowing access to the proximal surface of the couplingring 12. In FIG. 5 is shown a further preferred detail, viz. an upwardlyand outwardly protruding member 21 having an upper end 22 adapted to fitto the upper rim of the coupling ring for preventing the inner baglocking ring from being pushed in too deep when mounted.

[0055] It is believed that in the embodiments of an inner bag shown inFIGS. 4 and 5, certain dimensional proportions are preferred in order tofacilitate the use of the bag. The following dimensions are consideredas indicated in FIGS. 6-8, FIG. 6 showing a separate inner bag couplingring having an inner diameter d₁ and an outer diameter d₂, FIG. 7showing a flattened inner bag liner having an open end having a width W,and FIG. 8 showing the inner bag liner in open state with an essentiallycircular opening having diameter D1. The bag is widening to a diameterof at least the inner diameter d₁ of the inner bag coupling ring. Inorder to lock the bag securely it is preferred that D1<d₂ is fulfilled.When W>d₂ is fulfilled, the bag may easily be drawn through the ringwhen tilted and folded back and the locking is effected by raising thering to a position perpendicular to the centre line of the inner bagliner and pushing it outwards until reaching the point where thediameter of the bag is less than d₂.

1. An ostomy appliance comprising an adhesive barrier member (or baseplate), said barrier member having a hole for receiving a stoma, ureter,or catheter and barrier wafer to be attached to the wearer's abdomen,back, or chest; an outer receiving member or bag releasably attached tothe adhesive barrier member, said bag having a hole for receiving wastesexiting the stoma, ureter or catheter; and a disposable inner bag linerreleasably attached to the adhesive barrier member wherein thedisposable inner bag liner having a hole for receiving wastes exitingthe stoma, ureter or catheter is attached releasably to the adhesivebarrier member in a first coupling area by first coupling means and theouter receiving member is attached releasably to the adhesive barriermember by second coupling means, in which the first and second couplingareas are in the form of one or more coupling rings and the first andsecond coupling means are in the form of matching coupling rings,characterised in that the first and second coupling areas are located onone coupling ring for coupling a receiving member to the adhesivebarrier member and that the first coupling area is in the form of agroove at the inner side of the coupling ring or the lower inner edge ofthe coupling ring.
 2. An ostomy appliance as claimed in claim 1 whereinthe first and second coupling means are in the form of concentriccoupling rings.
 3. An ostomy appliance as claimed in claim 1 wherein thefirst and second coupling areas are located on one coupling ring forcoupling a receiving member to the adhesive barrier member and whereinthe first coupling surface is located at the inner surface of thecoupling ring and the second coupling surface is located at the outersurface of the coupling ring.
 4. An ostomy appliance as claimed in claim3 wherein the first coupling surface is in the form of a groove in theinner surface of the coupling ring.
 5. An ostomy appliance as claimed inclaim 3 wherein the first coupling surface is in the form of a recess atthe proximal side of the coupling ring.
 6. A disposable inner bag linerfor receiving effluents or waste products of the body and for usetogether with an ostomy appliance comprising an adhesive, flexible skinbarrier member for securing the appliance to the user's skin saidbarrier member having a hole for receiving a stoma, ureter, or catheterand barrier wafer to be attached to the wearer's abdomen, back, or chestand a collection bag having a hole for receiving wastes exiting thestoma, ureter or catheter wherein the disposable inner bag liner has ahole for receiving wastes exiting the stoma, ureter or catheter and isreleasably attachable to the adhesive barrier member in a first couplingarea by first coupling means and the collection bag by second couplingmeans, in which the first and second coupling areas are in the form ofone or more coupling rings and the first and second coupling means arein the form of matching coupling rings, characterised in that the firstcoupling means is adapted for coupling to a first coupling area locatedon a coupling ring for coupling a receiving member to the adhesivebarrier member and that the first coupling area is in the form of agroove at the inner side of the coupling ring or the lower inner edge ofthe coupling ring.
 7. A disposable inner bag liner as claimed in claim 6wherein the first coupling means is in the form of a coupling ring forengaging with a first coupling area located at the inner surface of acoupling ring for coupling a collection bag to the to the adhesivebarrier member.
 8. A disposable inner bag liner as claimed in claim 7wherein the first coupling means is in the form of an exchangeable innerbag coupling ring.
 9. A disposable inner bag liner as claimed in claim 8wherein the exchangeable coupling ring has an inner diameter d₁ and anouter diameter d₂ and the flattened inner bag has an open end having awidth W and the inner bag liner in the open state having an essentiallycircular opening has a diameter D1 wherein the relation D1<d₂ isfulfilled.
 10. A disposable inner bag liner as claimed in claim 9wherein the relation W>d2 is fulfilled.